MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-09-16 for EXTERNAL FETAL MONITOR * 30784014ATB22-44 manufactured by Graphic Controls.
[19540543]
Rptr opened a brand new package which had piece of what looked like black electrical tape on the belt. Rptr removed the tape to see what was under it and found that the belt had been cut and taped back together with black electrical tape. This must have been done at the factory.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1009927 |
| MDR Report Key | 38133 |
| Date Received | 1996-09-16 |
| Date of Report | 1996-09-12 |
| Date of Event | 1996-09-11 |
| Date Added to Maude | 1996-09-18 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXTERNAL FETAL MONITOR |
| Generic Name | MONITOR BELT FOR EXTERNAL FETAL MONITOR |
| Product Code | HFM |
| Date Received | 1996-09-16 |
| Model Number | * |
| Catalog Number | 30784014ATB22-44 |
| Lot Number | 9616340 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 39403 |
| Manufacturer | GRAPHIC CONTROLS |
| Manufacturer Address | 189 VAN RENSSELAER ST BUFFALO NY 142401274 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-09-16 |